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临床试验/NCT03851679
NCT03851679已完成不适用

Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia

University of Udine0 个研究点目标入组 80 人开始时间: 2016年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Ultrasound pulmonary variations

研究概览

简要总结

Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected.

Vascular permeability is controlled by endothelial glycocalyx. Several factors such as sepsis, ischemia / reperfusion, inflammatory mediators, trauma, surgery including the Cesarean Section and fluid overload can increase vascular permeability due to a glycocalyx damage.

During Cesarean Section under subarachnoid anesthesia, hypotension may occur. It is a common side effect caused by reduced preload due to aortocaval compression by the uterus. Furthermore, subarachnoid anesthesia causes block of the sympathetic preganglionic fibers which is associated with vasodilation. These changes often require the use of vasopressors and fluids.

A fluid overload associated with the physiological and pathological factors discussed earlier might cause an increased risk of pulmonary edema and acute respiratory failure (IRA) in women undergoing cesarean section under arachnoid anesthesia.

IRA occurs in less than 0.2% of total pregnancies but it is one of the most common cause of admission to intensive care unit in pregnant women.

Among the causes that can lead to IRA in the last trimester of pregnancy we find pneumopathies such as asthma, pulmonary embolism due to amniotic fluid and pulmonary edema related to severe preeclampsia.

Diagnosis of pulmonary edema can be clinical or sub-clinical through laboratory tests such as BNP (b-type natriuretic peptide). It might also be necessary to execute instrumental examinations such as chest radiography (contraindicated in pregnancy) or trans-thoracic ultrasound.

Hypothesis: correlation between subarachnoid anesthesia, fluidic therapy and BNP values and ultrasound pattern

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • woman submit elective Cesarean Section:
  • age > 18 years
  • American Society of Anesthesiologists (ASA) physical status classification system > 2
  • > 37 gestational age
  • arterial pressure >/ = 140/90 mmHg and proteinuria < 300 mmHg during anesthesia pre-examination
  • no known cardiovascular/respiratory disease
  • pre-partum pulmonary echography

排除标准

  • age < 18 years
  • pulmonary echographic windows not satisfying
  • blood loss during Cesarean Section more than 1000 mL and/or necessity to administer colloid
  • postpartum hemorrhage within the first 24 hours following childbirth
  • pre-eclamptic sign/symptoms within the first 5 days following childbirth
  • twin pregnancy

结局指标

主要结局

Ultrasound pulmonary variations

时间窗: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery

The main goal of our study is to evaluate, preoperatively, the incidence of ultrasound pulmonary variations in pregnant women attending elective Cesarean Section

次要结局

  • subclinical pulmonary echography variation(pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery)
  • B-type natriuretic peptide serum value variation(B-type natriuretic peptide serum level is sampled 30 minutes before Cesarean Section, 6 and 24 hours after surgery 30 minutes before Cesarean Section, 6 and 24 hours after surgery)
  • fluid administration and pulmonary echography variation(pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bove

Professor

University of Udine

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